Japan's Drug Approval-patent Linkage System and Its Implications for Us

Thirty-nine (39) new drugs have been approved by the U.S. FDA in 2012, a record highest number of approvals since 1996. The record is a sign that pharma companies are poised to tap recent advances from genomics and proteomics. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new products. Many life-saving drugs are approved for marketing. The list includes a total of 10 drugs for cancer treatment, and nearly a quarter of those approved in 2012 had orphan drug status. Among the breakthrough drugs approved in 2012 were ivacaftor (cystic fibrosis), vasmodegib (skin cancer), HPC-C (human cord blood product), ruxolitinib (myelofibrosis) and a new combination drug to treat HIV. In addition, several unique products were approved for the treatment of macular degeneration, chronic weight management, overactive bladder, actinic keratosis, erectile dysfunction, glaucoma, respiratory distress syndrome, and COPD. The approval of 39 drugs in 2012 underscores a robust success rate and confirms that innovation is once again beginning to pay off. In the existing climate of reduced revenues in the face of generic competitions, the future and survival of big companies rests heavily on their unique niche products. It is apparent that big Pharma and a growing number of emerging Biotechs alike have focused their attention on developing new NMEs for rare diseases. In 2012, the length of the FDA’s review is shorter than agencies in other countries. Innovative models adopted for R&D strategies, communications, and new regulatory changes appear to shorten development timelines. Despite record drug approvals, there is bleak scope for blockbusters because most of these drugs have a limited market. The pipeline for blockbusters appears very low. However, there is unmet medical need for new drugs in autism, Alzheimer’s disease and epilepsy. Overall, the new drug approval list unveils unique and reemerging trends indicating that the pharma companies are poised for big growth from new brands approved for marketing for narrow-spectrum indications.

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Patent Linkage and Data Exclusivity: A Look at Some Developments in India

SSRN Electronic Journal ◽

10.2139/ssrn.2691222 ◽

2011 ◽

Author(s):

Sandeep K. Rathod

Keyword(s):

Data Exclusivity ◽

Patent Linkage

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Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x07666200808163247 ◽

2020 ◽

Vol 07 ◽

Author(s):

Paramjeet Malik ◽

Neelam Pawar ◽

Kavita Bahmani

Keyword(s):

Generic Drugs ◽

Drug Product ◽

Drug Approval ◽

Approval Process ◽

Regulatory Requirements ◽

Team Members ◽

Regulatory Authorities ◽

Effective Manner ◽

Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

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COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v4i2.14 ◽

2016 ◽

Vol 4 (2) ◽

pp. 1-9

Author(s):

Lincy Joseph ◽

Mathew George ◽

Kalpesh K Malaviya ◽

Bincy K Chacko ◽

...

Keyword(s):

Generic Drug ◽

Drug Approval ◽

Evaluation Agency ◽

Approval Process ◽

Registration Process ◽

Regulatory Guidelines ◽

Food Drug Administration ◽

Government Websites ◽

Drug Approval Process ◽

Regulatory Sites

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements.

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MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v1i3.5 ◽

2013 ◽

Vol 1 (3) ◽

pp. 1-6

Author(s):

Pankaj Kashyap ◽

Eshant Duggal ◽

Parveen Budhwar ◽

Jitendra Kumar Badjatya

Keyword(s):

Generic Drug ◽

Patent Protection ◽

Drug Approval ◽

Approval Process ◽

Generic Medicines ◽

Healthcare Provision ◽

Pharmaceutical Markets ◽

Global Issue ◽

Drug Approval Process ◽

High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process.

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